Anesthesia, General
Conditions
Brief summary
Performance Assessment of the PMD-200, a Novel Pain Monitor, in Subjects at Neurointensive Care Unit.
Detailed description
The proposed study is design to further demonstrates the performance of the Nociception Level (NoL) Index in neurological impaired anesthetized patients under general anesthesia, by evaluating its response to controlled changes in the levels of noxious stimuli/analgesia, and to correlate the NoL response to the EEG derived pain score. Validating the performance of the NoL Index may provide a tool to monitor the pain/nociception in this population. In this study, the PI plan to demonstrate that the NoL Index is a continuous index. It is anticipated that a higher level of nociception will correspond to a higher NoL index. On the other hand, it is anticipated that higher levels of analgesic agent for the same noxious stimulus will lead to a lower NoL index. The participants will be monitored as in a typical ICU and according to the local guidelines by various types of monitoring devices, such as: vital signs, pulse oximeter, Bispectral Index (BIS), Electroencephalography (EEG) etc.
Interventions
DEVICEPMD-200
the patients will be monitored by PMD-200. The technology consists of measurements of a number of nociception-related physiological parameters that corresponds with the autonomic nervous system's response to noxious stimuli, and using the company's proprietary algorithms, 'translating' these measurements into an index that represents the nociceptive response, the NoL™ (Nociception Level) Index. The NoL index is a relative index from 0 to 100, while 0 is no pain/nociception and 100 is extreme pain/nociception.
DEVICEEEG monitor
An EEG device will be connected to the patient and display the Spectral Edge Frequency (SEF) signals and values on the subject monitor.
Sponsors
Medasense Biometrics Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years old. * The subject is under general anesthesia * The subject have a blood pressure measurement (either arterial or cuff) during the study * A signed Informed Consent Form (ICF) has been obtain
Exclusion criteria
\- The subject is constantly agitate or moving a lot
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between changes in the nociception levels of the subject (NoL Index value) prior and following a noxious stimuli | Through study completion, about one year | To demonstrate that the NoL Index is correlates with changes in the nociception levels of the subject prior and following a noxious stimuli. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between changes in the nociception levels of the subject (NoL Index value) to other nociception predictors (HR, NIBP) | Through study completion, about one year | The NoL values can be correlate to other nociception predictors (e.g heart rate, blood pressure) following a noxious stimuli. |
| Correlation between the NoL index and the EEG derived pain score | Through study completion, about one year | To assess the correlation between the NoL index and the EEG derived pain score during arousal response caused by noxious stimuli |
Countries
Israel
Outcome results
None listed